PROJECT SUMMARY: CLINICAL AND TRANSLATIONAL RESEARCH CENTER (CTRC) The Clinical and Translational Research Center (CTRC) is the dedicated MD Anderson site for complex biologically-based new drug evaluation. With its 32-room nursing treatment center and adjacent full-function research laboratory, the CTRC is an ideal location to perform intensive clinical trials with a focus on first-in- human, phase I, and phase II studies requiring rigorous time points and pharmacologic testing. The CTRC provides a distinct resource for physician-scientists and clinical investigators to develop new agents for cancer treatment by offering coordination of multidisciplinary research, regulatory compliance, budget development, intensive and time-sensitive monitoring of patients, phlebotomy, and prompt and accurate specimen processing, storage, tracking, and shipment. The CTRC director, Filip Janku, MD, PhD; co-director, Daniel Karp, MD; clinical administrative director, Brenda Brown, MSN, RN, OCN, NEA-BC; and assistant director, Passion Lockett, DrPH, CCRC, provide leadership through planning, directing, and coordinating the integration of services and transfer of knowledge between the CTRC and the other CCSG cores. Current services include biospecimen collection and processing ranging from basic pharmacokinetic sampling to cell isolation and enumeration. Major equipment includes 15 centrifuges, a biosafety cabinet, 6 ultra-low freezers, a cell culture analyzer, and an AeroScout freezer monitoring system. Demand for services has increased by 98% since the previous grant cycle, and the CTRC has met this demand by increasing efficiency and increasing capacity by expanding from 18 beds to 32. Over the 6-year period, the CTRC facilitated 193 cancer center members who produced 184 publications, with 92 (50%) in journals with IF >5 and 38 (21%) in journals with IF >10, including N Engl J Med, Lancet, Nature, Nat Med, J Clin Oncol, and Cancer Cell. The CTRC's total operating budget in the current grant year (Yr43) is $5,050,892, and the CCSG accounts for 4% ($213,297). A total of ~$600,000 was provided for research equipment ($55,402) and renovations. In Yr42, 110 cancer center members used the CTRC, and 55% of all usage was by peer review-funded users. All CCSG programs used the CTRC, with 38% of all usage by the Developmental Therapeutics Program, followed by the Stem Cell Transplantation and Cellular Therapy Program (13%). In Yr44, 4% ($218,178) is requested from the CCSG. The CTRC Specific Aims are: Aim 1: To leverage the infrastructure and support for transformative high-impact early-phase clinical trials; Aim 2: To develop, customize and implement a new clinical trials management system to increase efficiency, accountability, transparency, plus data and sample integrity; Aim 3: To implement tools to evaluate patients' satisfaction and deliver patient-centered clinical research; and Aim 4: To provide expertise, training and education to research staff, faculty, and trainees.